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Chemokine Receptor Antagonist

SX-682 + Decitabine for Myelodysplastic Syndrome

Phase 1

Recruiting

Led By David A Sallman, MD

Research Sponsored by Syntrix Biosystems, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2

IPSS intermediate-2 risk or high risk and failed treatment following 4 cycles hypomethylating agent

Must not have

Allergy to study drug component.

Any of the following cardiac abnormalities: QT interval > 480 msec corrected using Fridericia's formula, Risk factors for Torsade de Pointes, Use of medication that prolongs the QT interval, Myocardial infarction ≤ 6 months prior to first day of study drug treatment, Unstable angina pectoris or serious uncontrolled cardiac arrhythmia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 28 days in the 28 day cycle 1.

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the safety of a new drug, SX-682, in patients with Myelodysplastic Syndromes. The goal is to find the maximum tolerated dose and identify any dose-limiting toxicities.

Who is the study for?

This trial is for adults with Myelodysplastic Syndromes (MDS) who have not responded to previous treatments. Participants must have an acceptable level of kidney function, be in a relatively stable condition (ECOG ≤ 2), and not be pregnant or breastfeeding. They should also use contraception if applicable and cannot join if they've had certain heart issues, other cancers within the last 3 years, HIV, Hepatitis B/C, or are on specific medications.

What is being tested?

The study is testing SX-682 alone and combined with Decitabine taken orally or intravenously to find the safest dose that can be tolerated without severe side effects. It aims to establish what's called the maximum tolerated dose (MTD) and recommend a Phase 2 dose for further studies.

What are the potential side effects?

Potential side effects may include reactions at the injection site for IV drugs, fatigue, changes in blood counts leading to increased infection risk or bleeding problems. There could also be liver-related issues indicated by elevated enzymes AST/ALT and gastrointestinal symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

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My condition is high-risk and didn't improve after 4 treatments with a specific medication.

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My low or intermediate-1 risk cancer did not respond to specific treatments.

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My condition is low or intermediate-1 risk with 5q deletion, and treatments with lenalidomide did not work for me.

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I am a man and will use the specified contraception if sexually active.

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My kidney function, measured by GFR, is at least 30 ml/min.

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I have been diagnosed with MDS according to WHO standards.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to one of the components in the study drug.

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I have heart issues like abnormal ECG, recent heart attack, or use heart-related medications.

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I have not had major surgery in the last 4 weeks.

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I do not have any serious or uncontrolled health issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 28 days in the 28 day cycle 1.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 28 days in the 28 day cycle 1.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days in the 28 day cycle 1. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

SX-682 Dose Limiting Toxicities (DLT)

SX-682 Maximum Tolerated Dose (MTD)

Secondary study objectives

Adverse Events

Participants Experiencing a Treatment Response

SX-682 Delayed Dose Limiting Toxicities

+3 more

Side effects data

From 2023 Phase 1 & 2 trial • 12 Patients • NCT04574583

67%

Oral hemorrhage

67%

Neutrophil count decreased

67%

Injection site reaction

67%

Lipase increased

67%

White blood cell decreased

67%

Anemia

67%

Fatigue

33%

Abdominal pain

33%

Edema limbs

33%

Hypokalemia

33%

Lymphocyte count decreased

33%

Memory impairment

33%

Nausea

33%

Upper gastrointestinal hemorrhage

33%

Rectal hemorrhage

33%

Flu like symptoms

100%

80%

60%

40%

20%

Study treatment Arm

Phase I Dose Level 3 (DL3) 100 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa +CV301

Phase I Dose Level 1(DL1) 25mg SX-682 Monotherapy Sequentially Foll/by 1200mg BinTraFusp Alfa +CV301

Phase I Dose Level 2 (DL2) 50 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa + CV301

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups

Experimental Treatment

Group I: Expansion of SX-682 with decitabine (lower risk patients, naive to hypomethylating agents)Experimental Treatment2 Interventions

Expansion of oral doses of SX-682 (study drug) at 100 mg twice daily with decitabine in lower risk patients who have never received hypomethylating agents.

Group II: Expansion of SX-682 with decitabine (lower risk patients, failed on hypomethylating agents)Experimental Treatment2 Interventions

Expansion of oral doses of SX-682 (study drug) at 100 mg twice daily with decitabine in lower risk patients who failed on hypomethylating agents.

Group III: Expansion of SX-682 with decitabine (higher risk patients, naive to hypomethylating agents)Experimental Treatment2 Interventions

Expansion of oral doses of SX-682 (study drug) at 100 mg twice daily with decitabine in higher risk patients who have never received hypomethylating agents.

Group IV: Expansion of SX-682 with decitabine (higher risk patients, failed on hypomethylating agents)Experimental Treatment2 Interventions

Expansion of oral doses of SX-682 (study drug) at 100 mg twice daily with decitabine in higher risk patients who failed on hypomethylating agents.

Group V: Expansion of SX-682 alone (lower risk patients, naive to hypomethylating agents)Experimental Treatment1 Intervention

Expansion of oral doses of SX-682 (study drug) at 200 mg twice daily (recommended phase 2 dose) in lower risk patients who have never received hypomethylating agents.

Group VI: Expansion of SX-682 alone (lower risk patients, failed on hypomethylating agents)Experimental Treatment1 Intervention

Expansion of oral doses of SX-682 (study drug) at 200 mg twice daily (recommended phase 2 dose) in lower risk patients who failed on hypomethylating agents.

Group VII: Expansion of SX-682 alone (higher risk patients, failed on hypomethylating agents)Experimental Treatment1 Intervention

Expansion of oral doses of SX-682 (study drug) at 200 mg twice daily (recommended phase 2 dose) in higher risk patients who failed on hypomethylating agents.

Group VIII: Dose Escalation of SX-682Experimental Treatment1 Intervention

Escalating oral doses of SX-682 (study drug) of 25, 50, 100, 200 and 400 mg twice-daily (i.e., 50, 100, 200, 400 and 800 mg total each day.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Decitabine

2011

Completed Phase 3

~2370

SX-682

2020